An interventional study of Surgery and Drug treatment in Prolactinoma, sponsored by Zhebao Wu. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-11-20.
Sponsored by Zhebao Wu · Not applicable, Interventional, and Treatment
To study the in vivo expression of dopamine D2 receptors in prolactinoma and the predictive role of dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists.
The dopamine agonist(DA),such as cabergoline(CAB) and bromocriptine(BC), has been used widely in the treatment of prolactinomas, but its clinical use is hampered by intolerance and/or resistant in some patients. It had been showed that DA inhibit prolactin secretion by binding to and activating dopamine D2 receptors.PET-MR combined MR images with PET function images is substantial to evaluate the expression of dopamine D2 receptors.The aim is to study the in vivo expression of dopamine D2 receptors in prolactinoma and the predictive role of dopamine D2 receptors PET-MR imaging in the therapeutic effect of DA.
26 studies on the registry are indexed under Prolactinoma; 7 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 15 interventional studies indexed under Prolactinoma.
Browse Prolactinoma studies →Zhebao Wu is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects are treated with CAB tablets 2mg/week or BC tablets 7.5mg/day.The pituitary hormone levels, tumor volume,visual acuity and visual field scale will be measured every 3 months.MRI showed that the tumors shrunk significantly.
Drug: Drug treatment
Subjects are treated with CAB tablets 2mg/week or BC tablets 7.5mg/day.The pituitary hormone levels, tumor volume, visual acuity and visual field scale will be measured every 3 months. The CAB or BC fail to decrease prolactinoma size.
Other: Surgery
The medication will be stopped if failure to decrease prolactinoma size and the subjects will be advised to endoscopic transphenoidal pituitary surgery .
The medication will continue if DA causes tumors to shrink.
Change from baseline on PRL level
Record the result of PRL on every 3 month follow-up visit
Time frame: Up to 6 months
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）
Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visits
Time frame: Up to 6 months
Change from baseline of visual field scale
Record the Visual field scale on every 3 month follow-up visit, 0 = normal, no vision loss; 1 = one quadrant vision loss; 2 = two quadrants of vision loss; 3 = three quadrants of vision loss; 4 = four quadrants of vision loss but retain a central tubular vision; 5 = blind
Time frame: Up to 6 months
Change from baseline of visual acuity
Record the Visual acuity on every 3 month follow-up visit.
Time frame: Up to 6 months
No study locations are listed for this record.
Plan to share: No — The individual patient Data would not be shared to the third facility, but the sponsor hasn't decided whether to share the individual patient date to the other related studies hold by himself in the future.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Zhebao Wu